CGA, Toxicity and PROCTCAE
Anna Bodily
2024-12-5
CGA Scores at Baseline
| Measure | Mean (SD) | Median (IQR) | Range |
|---|---|---|---|
| HADS | 6.25 (4.57) | 5 (5) | 20.0 |
| IADL | 12.93 (1.83) | 14 (1) | 8.0 |
| MOS ADL | 60.67 (30.13) | 65 (55) | 100.0 |
| SOC ACT | 58.68 (24.24) | 58.33 (33.33) | 100.0 |
| SOC SUP | 87.69 (19.6) | 95.83 (18.75) | 87.5 |
\(~\)
Toxicity, Grade 3 & 4
| Category | Baseline | Visit 1 | Visit 2 | Visit 3 | Visit 4 |
|---|---|---|---|---|---|
| Hematological | 16 | 45 | 32 | 31 | 22 |
| Non-Hematological | 1 | 5 | 2 | 5 | 8 |
\(~\)
Toxicity, Grade 4
| Category | Baseline | Visit 1 | Visit 2 | Visit 3 | Visit 4 |
|---|---|---|---|---|---|
| Hematological | 5 | 16 | 8 | 6 | 4 |
| Non-Hematological | 0 | 0 | 1 | 1 | 1 |
In the Sarcopenia dataset:
Hematological Events: Anemia, WBC, ANC, ALC, Platelets
Non-hematological Events: Nausea, vomit, diarrhea,
constipation, fatigue, insomnia, URTI, cough fever, pnemonia,
Paresthesia, preipheral sensory neuropathy, creatinine In the
CGA dataset:
Hematological Events: Anemia, WBC, ANC, ALC,
Platelelets decreased Non-hematological Events: Nausea,
vomiting, diarrhea, constipation, fatigue, insomnia, URTI, cough, fever,
pneumonia, Paresthesia, peripheral sensory neuropathy grade,
creatinine
\(~\)
PROCTCAE Mean of Raw Composite Scores
| Domain | Baseline | Timepoint 1 | Timepoint 2 | Timepoint 3 | Timepoint 4 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean (SD) | Median (IQR) | Range | Mean (SD) | Median (IQR) | Range | Mean (SD) | Median (IQR) | Range | Mean (SD) | Median (IQR) | Range | Mean (SD) | Median (IQR) | Range | |
| Vomiting | 0.04 (0.21) | 0 ([0, 0]) | [0, 1] | 0.04 (0.21) | 0 ([0, 0]) | [0, 1] | 0.02 (0.15) | 0 ([0, 0]) | [0, 1] | 0.05 (0.22) | 0 ([0, 0]) | [0, 1] | 0.05 (0.22) | 0 ([0, 0]) | [0, 1] |
| Heartburn | 0.43 (0.62) | 0 ([0, 1]) | [0, 2] | 0.47 (0.63) | 0 ([0, 1]) | [0, 2] | 0.33 (0.52) | 0 ([0, 1]) | [0, 2] | 0.44 (0.67) | 0 ([0, 1]) | [0, 2] | 0.48 (0.74) | 0 ([0, 1]) | [0, 2] |
| Hiccups | 0.2 (0.58) | 0 ([0, 0]) | [0, 3] | 0.22 (0.52) | 0 ([0, 0]) | [0, 2] | 0.24 (0.53) | 0 ([0, 0]) | [0, 2] | 0.14 (0.35) | 0 ([0, 0]) | [0, 1] | 0.17 (0.38) | 0 ([0, 0]) | [0, 1] |
| Constipation | 0.61 (0.9) | 0 ([0, 1]) | [0, 3] | 0.85 (0.93) | 1 ([0, 1]) | [0, 3] | 0.85 (0.89) | 1 ([0, 2]) | [0, 3] | 0.7 (0.85) | 0 ([0, 1]) | [0, 3] | 0.64 (0.82) | 0 ([0, 1]) | [0, 3] |
| Diarrhea | 0.53 (0.66) | 0 ([0, 1]) | [0, 2] | 0.52 (0.71) | 0 ([0, 1]) | [0, 3] | 0.54 (0.68) | 0 ([0, 1]) | [0, 3] | 0.63 (0.66) | 1 ([0, 1]) | [0, 2] | 0.55 (0.73) | 0 ([0, 1]) | [0, 3] |
| Pain in Abdomen | 0.37 (0.74) | 0 ([0, 0.75]) | [0, 3] | 0.56 (0.72) | 0 ([0, 1]) | [0, 3] | 0.53 (0.67) | 0 ([0, 1]) | [0, 2] | 0.58 (0.76) | 0 ([0, 1]) | [0, 3] | 0.55 (0.74) | 0 ([0, 1]) | [0, 3] |
| Shortness of Breath | 0.65 (0.79) | 0.5 ([0, 1]) | [0, 3] | 0.6 (0.81) | 0 ([0, 1]) | [0, 3] | 0.72 (0.85) | 1 ([0, 1]) | [0, 3] | 0.72 (0.88) | 0 ([0, 1]) | [0, 3] | 0.76 (0.88) | 1 ([0, 1]) | [0, 3] |
| Dry Mouth | 0.64 (0.91) | 0 ([0, 1]) | [0, 3] | 0.76 (0.87) | 0.5 ([0, 1]) | [0, 3] | 0.84 (0.9) | 1 ([0, 1]) | [0, 3] | 0.74 (0.92) | 0 ([0, 1]) | [0, 3] | 0.78 (0.95) | 0 ([0, 2]) | [0, 3] |
| Cough | 0.41 (0.65) | 0 ([0, 1]) | [0, 2] | 0.29 (0.63) | 0 ([0, 0]) | [0, 3] | 0.35 (0.57) | 0 ([0, 1]) | [0, 2] | 0.35 (0.65) | 0 ([0, 1]) | [0, 3] | 0.29 (0.46) | 0 ([0, 1]) | [0, 1] |
| Arm or Leg Swelling | 0.22 (0.51) | 0 ([0, 0]) | [0, 2] | 0.3 (0.59) | 0 ([0, 0]) | [0, 2] | 0.33 (0.68) | 0 ([0, 0]) | [0, 2] | 0.43 (0.83) | 0 ([0, 0.75]) | [0, 3] | 0.48 (0.74) | 0 ([0, 1]) | [0, 3] |
| Pounding/Racing Heartbeat | 0.2 (0.45) | 0 ([0, 0]) | [0, 2] | 0.2 (0.46) | 0 ([0, 0]) | [0, 2] | 0.21 (0.47) | 0 ([0, 0]) | [0, 2] | 0.19 (0.39) | 0 ([0, 0]) | [0, 1] | 0.26 (0.5) | 0 ([0, 0]) | [0, 2] |
| Dry Skin | 0.43 (0.62) | 0 ([0, 1]) | [0, 2] | 0.4 (0.5) | 0 ([0, 1]) | [0, 1] | 0.63 (0.72) | 1 ([0, 1]) | [0, 3] | 0.6 (0.73) | 0 ([0, 1]) | [0, 2] | 0.36 (0.53) | 0 ([0, 1]) | [0, 2] |
| Hair Loss Amount | 0.15 (0.36) | 0 ([0, 0]) | [0, 1] | 0.2 (0.51) | 0 ([0, 0]) | [0, 2] | 0.28 (0.5) | 0 ([0, 0.5]) | [0, 2] | 0.26 (0.44) | 0 ([0, 0.5]) | [0, 1] | 0.24 (0.49) | 0 ([0, 0]) | [0, 2] |
| Numbness/Tingling in Hands/Feet | 0.55 (0.77) | 0 ([0, 1]) | [0, 3] | 0.57 (0.67) | 0 ([0, 1]) | [0, 3] | 0.7 (0.73) | 1 ([0, 1]) | [0, 3] | 0.64 (0.68) | 1 ([0, 1]) | [0, 3] | 0.69 (0.74) | 1 ([0, 1]) | [0, 3] |
| Mouth or Throat Sores | 0.2 (0.46) | 0 ([0, 0]) | [0, 2] | 0.14 (0.41) | 0 ([0, 0]) | [0, 2] | 0.07 (0.26) | 0 ([0, 0]) | [0, 1] | 0.28 (0.67) | 0 ([0, 0]) | [0, 3] | 0.21 (0.47) | 0 ([0, 0]) | [0, 2] |
| Dizziness | 0.28 (0.62) | 0 ([0, 0]) | [0, 3] | 0.42 (0.66) | 0 ([0, 1]) | [0, 2] | 0.44 (0.7) | 0 ([0, 1]) | [0, 3] | 0.51 (0.74) | 0 ([0, 1]) | [0, 3] | 0.55 (0.83) | 0 ([0, 1]) | [0, 3] |
| Ringing in Ears | 0.65 (0.95) | 0 ([0, 1]) | [0, 3] | 0.56 (0.89) | 0 ([0, 1]) | [0, 3] | 0.53 (0.83) | 0 ([0, 1]) | [0, 3] | 0.58 (0.91) | 0 ([0, 1]) | [0, 3] | 0.67 (0.95) | 0 ([0, 1]) | [0, 3] |
| Concentration Problems | 0.46 (0.63) | 0 ([0, 1]) | [0, 3] | 0.52 (0.68) | 0 ([0, 1]) | [0, 3] | 0.59 (0.7) | 0 ([0, 1]) | [0, 2] | 0.58 (0.76) | 0 ([0, 1]) | [0, 3] | 0.58 (0.62) | 1 ([0, 1]) | [0, 2] |
| Memory Problems | 0.41 (0.64) | 0 ([0, 1]) | [0, 3] | 0.45 (0.66) | 0 ([0, 1]) | [0, 3] | 0.6 (0.74) | 0 ([0, 1]) | [0, 3] | 0.51 (0.72) | 0 ([0, 1]) | [0, 3] | 0.64 (0.73) | 1 ([0, 1]) | [0, 3] |
| Pain | 1.09 (1.13) | 1 ([0, 2]) | [0, 3] | 1.16 (1.11) | 1 ([0, 2]) | [0, 3] | 1.12 (1.07) | 1 ([0, 2]) | [0, 3] | 1.02 (1.14) | 1 ([0, 2]) | [0, 3] | 1.14 (1.12) | 1 ([0, 2]) | [0, 3] |
| Aching Muscles | 0.7 (1.03) | 0 ([0, 1]) | [0, 3] | 0.62 (0.94) | 0 ([0, 1]) | [0, 3] | 0.77 (0.92) | 0 ([0, 2]) | [0, 3] | 0.77 (0.97) | 0 ([0, 1]) | [0, 3] | 0.81 (1.06) | 0 ([0, 1]) | [0, 3] |
| Aching Joints | 0.89 (0.99) | 1 ([0, 1]) | [0, 3] | 0.69 (0.97) | 0 ([0, 1]) | [0, 3] | 0.72 (0.88) | 0 ([0, 1]) | [0, 3] | 0.74 (0.95) | 0 ([0, 1.5]) | [0, 3] | 0.8 (1.03) | 0 ([0, 1]) | [0, 3] |
| Insomnia | 0.91 (0.98) | 1 ([0, 1]) | [0, 3] | 0.84 (0.85) | 1 ([0, 1]) | [0, 3] | 0.84 (0.78) | 1 ([0, 1]) | [0, 3] | 0.91 (0.92) | 1 ([0, 1]) | [0, 3] | 1.05 (0.91) | 1 ([0, 2]) | [0, 3] |
| Fatigue | 1.21 (0.88) | 1 ([1, 2]) | [0, 3] | 1.39 (0.88) | 1 ([1, 2]) | [0, 3] | 1.42 (0.85) | 1 ([1, 2]) | [0, 3] | 1.5 (0.9) | 1 ([1, 2]) | [0, 3] | 1.44 (0.88) | 1 ([1, 2]) | [0, 3] |
| Hot Flashes | 0.41 (0.75) | 0 ([0, 1]) | [0, 3] | 0.42 (0.75) | 0 ([0, 1]) | [0, 3] | 0.29 (0.55) | 0 ([0, 0]) | [0, 2] | 0.37 (0.69) | 0 ([0, 1]) | [0, 3] | 0.33 (0.65) | 0 ([0, 0.75]) | [0, 3] |
| Nosebleeds | 0.11 (0.31) | 0 ([0, 0]) | [0, 1] | 0.11 (0.32) | 0 ([0, 0]) | [0, 1] | 0.12 (0.39) | 0 ([0, 0]) | [0, 2] | 0.07 (0.26) | 0 ([0, 0]) | [0, 1] | 0.05 (0.22) | 0 ([0, 0]) | [0, 1] |
| Problems Tasting | 0.3 (0.68) | 0 ([0, 0]) | [0, 3] | 0.56 (0.79) | 0 ([0, 1]) | [0, 3] | 0.52 (0.76) | 0 ([0, 1]) | [0, 3] | 0.54 (0.79) | 0 ([0, 1]) | [0, 3] | 0.69 (0.91) | 0 ([0, 1]) | [0, 3] |
| Decreased Appetite | 0.33 (0.56) | 0 ([0, 1]) | [0, 2] | 0.41 (0.58) | 0 ([0, 1]) | [0, 2] | 0.3 (0.46) | 0 ([0, 1]) | [0, 1] | 0.45 (0.86) | 0 ([0, 1]) | [0, 3] | 0.57 (0.74) | 0 ([0, 1]) | [0, 3] |
| Nausea | 0.27 (0.57) | 0 ([0, 0]) | [0, 3] | 0.34 (0.56) | 0 ([0, 1]) | [0, 2] | 0.34 (0.58) | 0 ([0, 1]) | [0, 2] | 0.36 (0.63) | 0 ([0, 1]) | [0, 2] | 0.42 (0.71) | 0 ([0, 1]) | [0, 3] |
\(~\)
PROCTCAE Change from Baseline Average Composite Scores
| Domain | Baseline | Timepoint 1 | Timepoint 2 | Timepoint 3 | Timepoint 4 |
|---|---|---|---|---|---|
| Vomiting | 0 | 0.00 | -0.02 | 0.01 | 0.01 |
| Heartburn | 0 | 0.04 | -0.10 | 0.01 | 0.05 |
| Hiccups | 0 | 0.02 | 0.04 | -0.06 | -0.03 |
| Constipation | 0 | 0.24 | 0.24 | 0.09 | 0.03 |
| Diarrhea | 0 | -0.01 | 0.01 | 0.10 | 0.02 |
| Pain in Abdomen | 0 | 0.19 | 0.16 | 0.21 | 0.18 |
| Shortness of Breath | 0 | -0.05 | 0.07 | 0.07 | 0.11 |
| Dry Mouth | 0 | 0.12 | 0.20 | 0.10 | 0.14 |
| Cough | 0 | -0.12 | -0.06 | -0.06 | -0.12 |
| Arm or Leg Swelling | 0 | 0.08 | 0.11 | 0.21 | 0.26 |
| Pounding/Racing Heartbeat | 0 | 0.00 | 0.01 | -0.01 | 0.06 |
| Dry Skin | 0 | -0.03 | 0.20 | 0.17 | -0.07 |
| Hair Loss Amount | 0 | 0.05 | 0.13 | 0.11 | 0.09 |
| Numbness/Tingling in Hands/Feet | 0 | 0.02 | 0.15 | 0.09 | 0.14 |
| Mouth or Throat Sores | 0 | -0.06 | -0.13 | 0.08 | 0.01 |
| Dizziness | 0 | 0.14 | 0.16 | 0.23 | 0.27 |
| Ringing in Ears | 0 | -0.09 | -0.12 | -0.07 | 0.02 |
| Concentration Problems | 0 | 0.06 | 0.13 | 0.12 | 0.12 |
| Memory Problems | 0 | 0.04 | 0.19 | 0.10 | 0.23 |
| Pain | 0 | 0.07 | 0.03 | -0.07 | 0.05 |
| Aching Muscles | 0 | -0.08 | 0.07 | 0.07 | 0.11 |
| Aching Joints | 0 | -0.20 | -0.17 | -0.15 | -0.09 |
| Insomnia | 0 | -0.07 | -0.07 | 0.00 | 0.14 |
| Fatigue | 0 | 0.18 | 0.21 | 0.29 | 0.23 |
| Hot Flashes | 0 | 0.01 | -0.12 | -0.04 | -0.08 |
| Nosebleeds | 0 | 0.00 | 0.01 | -0.04 | -0.06 |
| Problems Tasting | 0 | 0.26 | 0.22 | 0.24 | 0.39 |
| Decreased Appetite | 0 | 0.08 | -0.03 | 0.12 | 0.24 |
| Nausea | 0 | 0.07 | 0.07 | 0.09 | 0.15 |
\(~\)
PROCTCAE Average Baseline Adjusted Scores
| Domain | Mean (SD) | Median (IQR) | range |
|---|---|---|---|
| Vomiting | 0.14 (0.35) | 0 (0, 0) | [0, 1] |
| Heartburn | 0.49 (0.73) | 0 (0, 1) | [0, 2] |
| Hiccups | 0.31 (0.56) | 0 (0, 1) | [0, 2] |
| Constipation | 0.98 (1.02) | 1 (0, 2) | [0, 3] |
| Diarrhea | 0.69 (0.87) | 0 (0, 1) | [0, 3] |
| Pain in Abdomen | 0.76 (0.83) | 1 (0, 1) | [0, 3] |
| Shortness of Breath | 0.82 (1.01) | 0 (0, 2) | [0, 3] |
| Dry Mouth | 0.82 (0.99) | 0 (0, 2) | [0, 3] |
| Cough | 0.44 (0.78) | 0 (0, 1) | [0, 3] |
| Arm or Leg Swelling | 0.67 (0.95) | 0 (0, 1) | [0, 3] |
| Pounding/Racing Heartbeat | 0.24 (0.53) | 0 (0, 0) | [0, 2] |
| Dry Skin | 0.64 (0.8) | 0 (0, 1) | [0, 3] |
| Hair Loss Amount | 0.36 (0.65) | 0 (0, 1) | [0, 2] |
| Numbness/Tingling in Hands/Feet | 0.52 (0.76) | 0 (0, 1) | [0, 3] |
| Mouth or Throat Sores | 0.36 (0.72) | 0 (0, 0.25) | [0, 3] |
| Dizziness | 0.67 (0.88) | 0 (0, 1) | [0, 3] |
| Ringing in Ears | 0.44 (0.81) | 0 (0, 1) | [0, 3] |
| Concentration Problems | 0.63 (0.88) | 0 (0, 1) | [0, 3] |
| Memory Problems | 0.53 (0.78) | 0 (0, 1) | [0, 3] |
| Pain | 0.96 (1.13) | 0 (0, 2) | [0, 3] |
| Aching Muscles | 0.78 (1.06) | 0 (0, 1) | [0, 3] |
| Aching Joints | 0.76 (1.15) | 0 (0, 2) | [0, 3] |
| Insomnia | 0.8 (1.01) | 0 (0, 2) | [0, 3] |
| Fatigue | 1.32 (1.22) | 2 (0, 2) | [0, 3] |
| Hot Flashes | 0.4 (0.72) | 0 (0, 1) | [0, 3] |
| Nosebleeds | 0.16 (0.42) | 0 (0, 0) | [0, 2] |
| Problems Tasting | 0.78 (0.96) | 0 (0, 1) | [0, 3] |
| Decreased Appetite | 0.8 (0.92) | 1 (0, 1) | [0, 3] |
| Nausea | 0.52 (0.76) | 0 (0, 1) | [0, 3] |
CGA Baseline Domains vs PROCTCAE Baseline Domains
CGA Baseline Domains vs PROCTCAE Timepoint 2 Domains
CGA Baseline Domains vs PROCTCAE Timepoint 3 Domains
CGA Baseline Domains vs PROCTCAE Timepoint 4 Domains
CGA Baseline Domains vs PROCTCAE Timepoint 5 Domains
Tox Grade 3+ Group Comparison of CGA Domains at Baseline (Hematological Events)
| CGA Domain | P-value | Mean Diff | Conf. Interval |
|---|---|---|---|
| HADscore | 0.1732 | -1.43 | [-3.500, 0.640] |
| IADLscore | 0.1466 | 0.59 | [-0.210, 1.390] |
| MOS_ADLscore | 0.3863 | 5.39 | [-6.930, 17.720] |
| SOCSUPscore | 0.2344 | 5.36 | [-3.570, 14.280] |
| SOCACTscore | 0.2423 | 6.17 | [-4.270, 16.600] |
- Mean Diff is calculated by Group 1 - Group 2
Group 1: Those who had a hematological event
Group 2: Those who did not
Tox Grade 3+ Group Comparison of CGA Domains at Baseline (Non-Hematological Events)
| CGA Domain | P-value | Mean Diff | Conf. Interval |
|---|---|---|---|
| HADscore | 0.0043 | 4.29 | [1.490, 7.090] |
| IADLscore | 0.0142 | -1.67 | [-2.970, -0.370] |
| MOS_ADLscore | 0.0115 | -20.37 | [-35.790, -4.960] |
| SOCSUPscore | 0.8159 | -0.93 | [-8.920, 7.060] |
| SOCACTscore | 0.9523 | -0.42 | [-14.880, 14.040] |
- Mean Diff is calculated by Group 1 - Group 2
Group 1: Those who had a non-hematological event
Group 2: Those who did not
PROCTCAE 3 Group Comparison of CGA Domains at Baseline
| CGA Domain | P-value | Mean Diff | Conf. Interval |
|---|---|---|---|
| HADscore | 0.0150 | 2.25 | [0.450, 4.050] |
| IADLscore | 0.7265 | -0.13 | [-0.860, 0.600] |
| MOS_ADLscore | 0.4932 | -4.22 | [-16.420, 7.970] |
| SOCSUPscore | 0.8791 | 0.62 | [-7.490, 8.740] |
| SOCACTscore | 0.0106 | -12.36 | [-21.770, -2.950] |
- Mean Diff is calculated by Group 1 - Group 2
Group 1: Those who had a PROCTCAE composite score of 3 for any symptom at any timepoint
Group 2: Those who did not