Table 4.
Frequency of Nonserious and Serious Adverse Events Classified as MedDRA-Preferred Terms and Grouped by System Organ Class.a
| System Organ Class | Preferred Term | All Patients, n = 56 (671) | Combined Therapy, n = 43 (474) | VA Therapy, n = 12 (129) | mAb Therapy, n = 8 (68) |
|---|---|---|---|---|---|
| Blood and lymphatic system | Anemia (m, c) | 1 | — | — | 1 |
| Granulocytopenia (m, c) | 1 | 1 | — | — | |
| Leucopenia (m, c) | 20 | 9 | — | 11 | |
| Neutropenia (m, c) | 2 | 1 | — | 1 | |
| Thrombocytopenia (m, c) | 2 | 2 | — | — | |
| Gastrointestinal | Colitis (m, c) | 1 | 1 | — | — |
| Diarrhea (m, c, v) | 6 | 6 | — | — | |
| Nausea/Vomiting (m, c, v) | 7 (5) | 7 (5) | — | — | |
| Stomatitis/Mucositis (m, c) | 9 | 9 | — | — | |
| General disorders and administration site | Asthenia (m, c) | 2 (1) | 1 (1) | — | 1 |
| Chills (m, v, c) | 4 | 4 | — | — | |
| Decreased appetite (m, c) | 1 | 1 | — | — | |
| Fatigue (m, v, c) | 2 | 2 | — | — | |
| Hyperhidrosis (m, c) | 1 | 1 | — | — | |
| Malaise (m, v, c) | 6 (3) | 4 (2) | — | 2 (1) | |
| Pain (m, v, c) | 1 | 1 | — | — | |
| Pyrexia (m, v, c) | 2 | 2 | — | — | |
| Swelling (m, v, c) | 1 | 1 | — | — | |
| Unspecified hospitalization (m, v, c) | 2 (2) | — | 1 (1) | 1 (1) | |
| Immune system | Hypersensitivity (m, v, c) | 2 | 2 | — | — |
| Infections and infestations | Abscess (c) | 2 (1) | 2 (1) | — | — |
| Eye infection (m, c) | 2 | 2 | — | — | |
| Fungal infection (m, c) | 1 | — | — | 1 | |
| Gingivitis (m, c) | 1 | 1 | — | — | |
| Oral herpes | 1 | 1 | — | — | |
| Pyelonephritis (m, c) | 1 (1) | 1 (1) | — | — | |
| Septic encephalopathy | 1 (1) | 1 (1) | — | — | |
| Skin infection (m, c) | 1 | 1 | — | — | |
| Stoma site infection (m, c) | 1 | — | — | 1 | |
| Urinary tract infection (m, c) | 3 | 3 | — | — | |
| Urosepsis (c) | 1 (1) | 1 (1) | — | — | |
| Musculoskeletal and connective tissue | Back pain (m, c) | 1 | 1 | — | — |
| Nervous system | Cognitive disorder (c) | 2 (2) | 2 (2) | — | — |
| Dizziness (m, c) | 3 (3) | 3 (3) | — | — | |
| Polyneuropathy (c) | 5 (1) | 4 (1) | — | 1 | |
| Somnolence (m, c) | 2 (2) | 2 (2) | — | — | |
| Renal and urinary | Bladder disorder (m, c) | 1 | 1 | — | — |
| Enuresis | 2 (2) | 2 (2) | — | — | |
| Respiratory, thoracic, and mediastinal | Dyspnea (m, c) | 1 | 1 | — | — |
| Rhinorrhea (m, v, c) | 1 | 1 | — | — | |
| Skin and subcutaneous | Acneiform rash (m) | 12 | 10 | — | 2 |
| Dry skin (m, c) | 3 | 3 | — | — | |
| Eczema (m, c) | 1 | 1 | — | — | |
| Generalized erythema (m, v, c) | 2 | 2 | — | — | |
| Palmar-plantar erythrodysesthesia (m, c) | 3 | 3 | — | — | |
| Pruritus (m, v, c) | 5 | 2 | 3 | — | |
| Rosacea | 1 | 1 | — | — | |
| Skin reaction/Rash (unspecified) (m, v, c) | 7 | 4 | 3 | — | |
| Urticaria (m, v, c) | 1 | — | — | — | |
| Vascular disorders | Hemorrhage (m, c) | 1 (1) | 1 (1) | — | — |
| Total | 142 (26 SAE) | 112 (23 SAE) | 8 (1 SAE) | 22 (2 SAE) |
Abbreviations: MeDRA, Medical Dictionary for Regulatory Activities; VA, Viscum album L; mAb, monoclonal antibodies; n, number of patients with the number of treatment exposures in parentheses; SAE, serious adverse events.
a
Values represent the total number of documented adverse events, with the number of events classified as serious shown in parentheses. Causality was not attributed to adverse events because many of the events could have been reactions to concomitantly applied mAb (m), chemotherapeutic agents (c), VA (v), and/or supportive therapies (not indicated).