Table 2.
Total AEs
| Toxicity category | CDUS/CTCAE code | AE grade | All grades of AE | Possibly-definitively related to PANO? | |||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||||
| Gastrointestinal disorders* | Diarrhea | — | — | 2 (5.3) | — | 2 (5.3) | Yes |
| Nausea | — | — | 1 (2.6) | — | 1 (2.6) | Yes | |
| General disorders and administration site conditions* | Edema limbs | 1 (2.6) | — | — | — | 1 (2.6) | Yes |
| Investigations* | Neutrophil count decreased | — | — | 2 (5.3) | 4 (10.5) | 6 (15.8) | Yes |
| Platelet count decreased | — | — | 1 (2.6) | 4 (10.5) | 5 (13.2) | Yes | |
| Renal and urinary disorders* | Acute kidney injury | 1 (2.6) | — | — | — | 1 (2.6) | Yes |
| Skin and subcutaneous tissue disorders* | Periorbital edema | 1 (2.6) | — | — | — | 1 (2.6) | Yes |
| Rash maculo-papular | 1 (2.6) | — | 3 (7.9) | — | 4 (10.5) | Yes | |
| Blood and lymphatic system disorders | Leukocytosis | 1 (2.6) | — | — | — | 1 (2.6) | No |
| Cardiac disorders | Atrial fibrillation | — | 2 (5.3) | — | — | 2 (5.3) | No |
| Eye disorders | Floaters | 1 (2.6) | — | — | — | 1 (2.6) | No |
| Gastrointestinal disorders | Diarrhea | — | — | 2 (5.3) | — | 2 (5.3) | No |
| Nausea | — | — | 1 (2.6) | — | 1 (2.6) | No | |
| General disorders and administration site conditions | Edema limbs | 1 (2.6) | — | — | — | 1 (2.6) | No |
| Fever | 1 (2.6) | — | — | — | 1 (2.6) | No | |
| Non-cardiac chest pain | — | — | 1 (2.6) | — | 1 (2.6) | No | |
| Immune system disorders | Immune system disorders—other, specify | — | — | 1 (2.6) | — | 1 (2.6) | No |
| Infections and infestations | Appendicitis | — | — | 1 (2.6) | — | 1 (2.6) | No |
| Encephalitis infection | — | — | 1 (2.6) | — | 1 (2.6) | No | |
| Lung infection | — | — | 1 (2.6) | 1 (2.6) | 2 (5.3) | No | |
| Papulopustular rash | 1 (2.6) | — | — | — | 1 (2.6) | No | |
| Sepsis | — | — | — | 1 (2.6) | 1 (2.6) | No | |
| Sinusitis | — | 1 (2.6) | 1 (2.6) | — | 2 (5.3) | No | |
| Investigations | Neutrophil count decreased | — | — | 1 (2.6) | 3 (7.9) | 4 (10.5) | No |
| Platelet count decreased | — | — | 2 (5.3) | 2 (5.3) | No | ||
| Weight loss | 1 (2.6) | — | — | 1 (2.6) | No | ||
| Metabolism and nutrition disorders | Anorexia | — | — | 1 (2.6) | — | 1 (2.6) | No |
| Hypocalcemia | 4 (10.5) | — | — | — | 4 (10.5) | No | |
| Nervous system disorders | Akathisia | 1 (2.6) | — | 1 (2.6) | — | 2 (5.3) | No |
| Headache | 1 (2.6) | — | — | — | 1 (2.6) | No | |
| Myelitis | 2 (5.3) | — | — | — | 2 (5.3) | No | |
| Syncope | — | — | 1 (2.6) | — | 1 (2.6) | No | |
| Psychiatric disorders | Confusion | — | — | 1 (2.6) | — | 1 (2.6) | No |
| Hallucinations | 1 (2.6) | — | — | — | 1 (2.6) | No | |
| Renal and urinary disorders | Acute kidney injury | — | — | 1 (2.6) | — | 1 (2.6) | No |
| Respiratory, thoracic and mediastinal disorders | Cough | 1 (2.6) | — | — | — | 1 (2.6) | No |
| Pleural effusion | — | — | 1 (2.6) | — | 1 (2.6) | No | |
| Pneumonitis | — | — | 1 (2.6) | — | 1 (2.6) | No | |
| Pulmonary edema | — | — | 1 (2.6) | — | 1 (2.6) | No | |
| Skin and subcutaneous tissue disorders | Palmar-plantar erythrodysesthesia syndrome | — | 1 (2.6) | — | — | 1 (2.6) | No |
| Periorbital edema | 1 (2.6) | — | — | — | 1 (2.6) | No | |
| Rash maculo-papular | — | 1 (2.6) | — | 1 (2.6) | No | ||
| Vascular disorders | Hypertension | — | — | 1 (2.6) | — | 1 (2.6) | No |
CDUS, Clinical Data Update System.
*
Consider probably related to PANO.