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Table 4 Treatment-emergent adverse events, regardless of causality

From: Randomized phase II study of the PDGFRα antibody olaratumab plus liposomal doxorubicin versus liposomal doxorubicin alone in patients with platinum-refractory or platinum-resistant advanced ovarian cancer

 

No. (%)

Olaratumab + Liposomal Doxorubicin (n = 62)

Liposomal Doxorubicin (n = 61)

 

All grades

Grade ≥ 3

All grades

Grade ≥ 3

Patients with any TEAE

62 (100.0)

37 (59.7)

61 (100.0)

40 (65.6)

Consolidated TEAE categorya

 Fatigueb

38 (61.3)

7 (11.3)

38 (62.3)

1 (1.6)

 Mucositisc

30 (48.4)

0

28 (45.9)

4 (6.6)

 Rashd

27 (43.5)

3 (4.8)

18 (29.5)

5 (8.2)

 Abdominal paine

24 (38.7)

2 (3.2)

30 (49.2)

8 (13.1)

 Neutropeniaf

20 (32.3)

8 (12.9)

13 (21.3)

5 (8.2)

 Neuropathyg

12 (19.4)

0

9 (14.8)

0

 Hypomagnesemiah

10 (16.1)

0

6 (9.8)

1 (1.6)

Preferred termsa,i

 Nausea

35 (56.5)

2 (3.2)

39 (63.9)

1 (1.6)

 Constipation

32 (51.6)

2 (3.2)

24 (39.3)

0

 Vomiting

21 (33.9)

3 (4.8)

20 (32.8)

6 (9.8)

 Palmar-plantar erythrodysesthesia syndrome

21 (33.9)

7 (11.3)

27 (44.3)

4 (6.6)

 Diarrhea

19 (30.6)

2 (3.2)

13 (21.3)

0

 Back pain

16 (25.8)

1 (1.6)

10 (16.4)

1 (1.6)

 Abdominal distension

15 (24.2)

2 (3.2)

6 (9.8)

2 (3.3)

 Urinary tract infection

15 (24.2)

0

5 (8.2)

2 (3.3)

 Headache

12 (19.4)

0

7 (11.5)

1 (1.6)

 Anemia

10 (16.1)

3 (4.8)

13 (21.3)

1 (1.6)

 Dysgeusia

10 (16.1)

0

3 (4.9)

0

 Dehydration

9 (14.5)

3 (4.8)

3 (4.9)

2 (3.3)

 Weight decreased

8 (12.8)

0

4 (6.6)

0

 Proteinuria

7 (11.3)

0

2 (3.3)

0

 Muscle spasms

7 (11.3)

0

3 (4.9)

0

 Pain in extremity

4 (6.5)

0

9 (14.8)

1 (1.6)

TEAE of special interest

 Infusion-related reactionsj

6 (9.7)

0

3 (4.9)

0

 Any SAE

27 (43.5)

21 (33.9)

23 (37.7)

20 (32.8)

 Discontinuation due to TEAE

2 (3.2)

n.r.

7 (11.5)

n.r.

  1. AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; n.r., not reported; SAE, serious adverse event; TEAE, treatment-emergent adverse event
  2. aTEAEs occurring in ≥10% of patients (all grades) and with a ≥ 5% between-arm difference (all grades or grade ≥ 3)
  3. bConsolidated term comprising the following synonymous MedDRA preferred terms: fatigue and asthenia
  4. cConsolidated term comprising the following synonymous MedDRA preferred terms: aphthous stomatitis, mucosal inflammation, oropharyngeal pain, and stomatitis
  5. dConsolidated term comprising the following synonymous MedDRA preferred terms: rash, rash follicular, rash generalized, rash macular, rash papular, rash pruritic, and rash pustular
  6. eConsolidated term comprising the following synonymous MedDRA preferred terms: abdominal pain, abdominal pain lower, and abdominal pain upper
  7. fConsolidated term comprising the following synonymous MedDRA preferred terms: leukopenia, neutropenia, neutrophil count decreased, and white blood cell count decreased
  8. gConsolidated term comprising the following synonymous MedDRA preferred terms: hypoesthesia, neuropathy peripheral, paraesthesia, and peripheral sensory neuropathy
  9. hConsolidated term comprising the following synonymous MedDRA preferred terms: blood magnesium decreased, hypomagnesemia, and magnesium deficiency
  10. iOmits preferred terms that are included in consolidated categories
  11. jInfusion-related reactions include a combination of specific preferred terms such as infusion-related reactions, anaphylaxis, and signs and symptoms such as flushing and itching
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BMC Cancer

ISSN: 1471-2407

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