Table 2.
Severity of TEAEs (safety analysis set)
| Worst NCI-CTCAE grade | Part 2d total (N = 59) | ||||
|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
| Hematologic (>10% total) | |||||
| Anemiaa | 1 (1.7) | 7 (11.9) | 14 (23.7) | 1 (1.7) | 0 |
| Platelet count decreasedb | 9 (15.3) | 4 (6.8) | 6 (10.2) | 3 (5.1) | 0 |
| Neutrophil count decreasedc | 0 | 9 (15.3) | 8 (13.6) | 4 (6.8) | 0 |
| White blood cell count decreasedd | 1 (1.7) | 5 (8.5) | 8 (13.6) | 3 (5.1) | 0 |
| Gastrointestinal (>10% total) | |||||
| Nausea | 26 (44.1) | 16 (27.1) | 2 (3.4) | 0 | 0 |
| Vomiting | 24 (40.7) | 6 (10.2) | 1 (1.7) | 0 | 0 |
| Diarrhea | 12 (20.3) | 7 (11.9) | 0 | 0 | 0 |
| Constipation | 12 (20.3) | 3 (5.1) | 1 (1.7) | 0 | 0 |
| Stomatitise | 7 (11.9) | 2 (3.4) | 1 (1.7) | 0 | 0 |
| Abdominal painf | 4 (6.8) | 3 (5.1) | 1 (1.7) | 0 | 0 |
| Nervous system disorders (>10% total) | |||||
| Dysgeusia | 8 (13.6) | 1 (1.7) | 0 | 0 | 0 |
| Dizziness | 7 (11.9) | 1 (1.7) | 0 | 0 | 0 |
| Other (>10% total) | |||||
| Decreased appetite | 15 (25.4) | 16 (27.1) | 4 (6.8) | 0 | 0 |
| Fatigue | 11 (18.6) | 9 (15.3) | 1 (1.7) | 0 | 0 |
| Alopecia | 13 (22.0) | 7 (11.9) | 0 | 0 | 0 |
| Malaise | 13 (22.0) | 0 | 0 | 0 | 0 |
| Weight decreased | 3 (5.1) | 6 (10.2) | 2 (3.4) | 0 | 0 |
| Pyrexia | 5 (8.5) | 4 (6.8) | 0 | 0 | 0 |
| Hypokalemia | 8 (13.6) | 0 | 1 (1.7) | 0 | 0 |
| Epistaxis | 8 (13.6) | 0 | 0 | 0 | 0 |
| Hiccups | 6 (10.2) | 1 (1.7) | 0 | 0 | 0 |
| Dehydration | 2 (3.4) | 5 (8.5) | 0 | 0 | 0 |
| Blood alkaline phosphatase increased | 6 (10.2) | 1 (1.7) | 0 | 0 | 0 |
| Cough | 3 (5.1) | 3 (5.1) | 0 | 0 | 0 |
| Nasopharyngitis | 5 (8.5) | 1 (1.7) | 0 | 0 | 0 |
| Dry skin | 6 (10.2) | 0 | 0 | 0 | 0 |
| Peripheral edema | 4 (6.8) | 2 (3.4) | 0 | 0 | 0 |
| AEs of interest | |||||
| AST increased | 7 (11.9) | 2 (3.4) | 3 (5.1) | 0 | 0 |
| ALT decreased | 5 (8.5) | 1 (1.7) | 2 (3.4) | 0 | 0 |
| Ejection fraction decreased | 1 (1.7) | 4 (6.8) | 0 | 0 | 0 |
| Electrocardiogram QT prolonged | 0 | 1 (1.7) | 0 | 0 | 0 |
| Interstitial lung diseaseg | 1 (1.7) | 0 | 0 | 0 | 0 |
| Pneumonitisg | 3 (5.1) | 1 (1.7) | 1 (1.7) | 0 | 0 |
| Organizing pneumoniag | 0 | 0 | 0 | 0 | 1 (1.7)h |
| Blood bilirubin increased | 0 | 0 | 0 | 0 | 0 |
| Infusion-related reactions | 0 | 0 | 0 | 0 | 0 |
NOTE: Data are presented as n (%). Data cutoff for this analysis was February 1, 2019. Safety analysis set included all patients who received ≥1 dose of T-DXd. Although patients may experience more than one event per system organ class and preferred term, each patient is counted once for the worst CTCAE grade. One patient may be counted toward ≥2 preferred terms in the same system organ class category. System Organ Class was coded with Medical Dictionary for Regulatory Activities (MedDRA) version 20.1.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events.
Anemia includes hemoglobin decrease, red blood cell count decrease, and anemia.
Platelet count decrease includes platelet count decrease and thrombocytopenia.
Neutrophil count decrease includes neutrophil count decrease and neutropenia.
White blood cell count decrease includes leukopenia and white blood cell count decrease.
Stomatitis includes stomatitis, aphthous stomatitis, mouth ulceration, oral mucosa erosion, and oral mucosal blistering.
Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, and abdominal pain upper.
As assessed by the investigator before independent adjudication.
Drug-related ILD as determined by the independent ILD adjudication committee; includes one grade 5 case of respiratory failure adjudicated as drug related.