Table 4.
Adverse events per treatment group.
| System Organ Class | Adverse Event (AE) | Total n = 242 |
CTRL n = 160 |
COMB n = 82 |
|---|---|---|---|---|
| gastrointestinal disorders | nausea | 2 | a 1), d 4) | - |
| appetite loss | 1 | d 4) | - | |
| vomiting | 1 | d 4) | - | |
| general disorders and administration site conditions | pain | 1 | c 3)* | - |
| temperature elevated | 1 | b 2)* | - | |
| fatigue | 1 | e 5) | - | |
| neck stiffness | 1 | e 5) | - | |
| impaired vision | 1 | e 5) | - | |
| skin and subcutaneous tissue disorder | erythema | 1 | e 5) | - |
| Total number of AEs | 10 | 10 | - | |
| Total number of patients experiencing AE | 5 | 5 | 0 | |
| AE per patient frequency (AE events divided by number of all patients, n (%) §) | 4.13% §) | 6.25% | 0 | |
| Patient with AE frequency (patient experiencing an AE divided by number of all patients) §§) | 2.07% §§) | 3.13% | 0 |
Adverse events per treatment group classified as MedDRA (MedDRA Version 24.1) preferred terms and grouped by system organ class; each letter a-e indicate a different patient, same letters indicate the same patient; 1) pertuzumab; 2) trastuzumab; 3) trastuzumab/pertuzumab, 4) niraparib; 5) pazopanib, * treatment was discontinued; AE, adverse event; §) comparison of AE frequency COMB group vs. CTRL group: χ2 = 0.107, p-value = 0.99; §§) comparison of AE frequency COMB group vs. CTRL group: χ2 = 1.3, p-value = 0.25.