Anastrozole (Page 2 of 10)

First-Line Therapy

Adverse reactions occurring with an incidence of at least 5% in either treatment group of trials 0030 and 0027 during or within 2 weeks of the end of treatment are shown in Table 3.

Table 3 — Adverse Reactions Occurring with an Incidence of at Least 5% in Trials 0030 and 0027

Body system

Adverse Reaction *

Number (%) of subjects

Anastrozole

(N=506)

Tamoxifen

(N=511)

*
A patient may have had more than 1 adverse event.

Whole body

Asthenia

83 (16)

81 (16)

Pain

70 (14)

73 (14)

Back pain

60 (12)

68 (13)

Headache

47 (9)

40 (8)

Abdominal pain

40 (8)

38 (7)

Chest pain

37 (7)

37 (7)

Flu syndrome

35 (7)

30 (6)

Pelvic pain

23 (5)

30 (6)

Cardiovascular

Vasodilation

128 (25)

106 (21)

Hypertension

25 (5)

36 (7)

Digestive

Nausea

94 (19)

106 (21)

Constipation

47 (9)

66 (13)

Diarrhea

40 (8)

33 (6)

Vomiting

38 (8)

36 (7)

Anorexia

26 (5)

46 (9)

Metabolic and Nutritional

Peripheral edema

51 (10)

41 (8)

Musculoskeletal

Bone pain

54 (11)

52 (10)

Nervous

Dizziness

30 (6)

22 (4)

Insomnia

30 (6)

38 (7)

Depression

23 (5)

32 (6)

Hypertonia

16 (3)

26 (5)

Respiratory

Cough increased

55 (11)

52 (10)

Dyspnea

51 (10)

47 (9)

Pharyngitis

49 (10)

68 (13)

Skin and appendages

Rash

38 (8)

34 (8)

Urogenital

Leukorrhea

9 (2)

31 (6)

Less frequent adverse experiences reported in patients receiving anastrozole 1 mg in either Trial 0030 or Trial 0027 were similar to those reported for second-line therapy.

Based on results from second-line therapy and the established safety profile of tamoxifen, the incidences of 9 pre-specified adverse event categories potentially causally related to one or both of the therapies because of their pharmacology were statistically analyzed. No significant differences were seen between treatment groups.

Table 4 — Number of Patients with Pre-specified Adverse Reactions in Trials 0030 and 0027

Number (n) and Percentage of Patients

Adverse Reaction *

Anastrozole

1 mg

(N=506)

n (%)

NOLVADEX

20 mg

(N=511)

n (%)

*
A patient may have had more than 1 adverse reaction.
Includes pulmonary embolus, thrombophlebitis, retinal vein thrombosis.
Includes myocardial infarction, myocardial ischemia, angina pectoris, cerebrovascular accident, cerebral ischemia and cerebral infarct.

Depression

23 (5)

32 (6)

Tumor Flare

15 (3)

18 (4)

Thromboembolic Disease

18 (4)

33 (6)

Venous

5

15

Coronary and Cerebral

13

19

Gastrointestinal Disturbance

170 (34)

196 (38)

Hot Flushes

134 (26)

118 (23)

Vaginal Dryness

9 (2)

3 (1)

Lethargy

6 (1)

15 (3)

Vaginal Bleeding

5 (1)

11 (2)

Weight Gain

11 (2)

8 (2)

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